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Nicotine Patch, Blood Flow and Oxidative Stress Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954096
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : October 27, 2009
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania

Brief Summary:
This study will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

Condition or disease Intervention/treatment Phase
Healthy Drug: transdermal nicotine patch (7mg) Not Applicable

Detailed Description:

Smoking causes >400,000 deaths from cardiovascular disease (CVD) per year. The molecular basis of smoking induced tissue injury remains unclear but considerable evidence supports a role for oxidant stress (OS).

Arterial function has been shown to be impaired in smokers even before the onset of angiographically demonstrable atherosclerosis. Defects in endothelium dependant flow mediated vasodilatation (FMD) are seen in those at risk of or with overt vascular disease.

Cigarette smoking is highly addictive. Spontaneous quit rates approximate 3%. Even those using nicotine replacement therapy (NRT) have high relapse rates (67-75%) on completion of the 8-12 week course of NRT. Thus there is interest in the use of extended NRT as a "safer" alternative to cigarette smoking. However such assumptions may be premature. Nicotine demonstrates proxidant effects in vitro and in small studies has been associated with endothelial dysfunction. Studies simultaneously assessing the effects of nicotine on oxidative stress and arterial function in humans have not been performed.

The current proposal will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effect Of Nicotine On Indices Of Arterial Function And Oxidative Stress
Study Start Date : October 2002
Actual Primary Completion Date : November 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Transdermal nicotine patch or placebo
A single blood specimen (85ml) will be drawn. They will be asked to empty their bladder. The patch will be applied. Following application of the patch, heart rate and blood pressure will be measured every 15 minutes for the 1st hour, every 30 minutes for the next 3 hours and hourly after that until the end of the study. Urine will be collected in two 4-hour aliquots. FMD will be measured after approximately 6 hours of nicotine exposure. After 8 hours exposure, following the end of the 2nd urine collection, the patch will be removed and the subject discharged. Following a minimum of 2 weeks (maximum 8 weeks) washout, the subject will repeat the study, receiving the other patch.
Drug: transdermal nicotine patch (7mg)
A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.
Other Names:
  • Nicotine patch
  • Habitrol
  • Nicoderm CQ
  • Nicotrol

Primary Outcome Measures :
  1. Assess the dose-related effects of nicotine in humans, on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts. [ Time Frame: 1 - 3 years ]

Secondary Outcome Measures :
  1. Assess the dose-related effects of nicotine in humans on COX activation. [ Time Frame: 1 year ]
  2. Assess the dose-related effects of nicotine in humans on blood flow mediated arterial function. [ Time Frame: 3 - 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy individuals
  • Nonsmokers who have never smoked
  • Normal medical history
  • Normal physical examination
  • Normal laboratory data
  • Negative urinary pregnancy test for females

Exclusion Criteria:

  • Previous CVD
  • Chronic medication use
  • History alcoholism
  • History of smoking
  • Current pregnancy
  • Subjects, who have less than or equal to 60% platelet aggregation in response to arachidonic acid will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954096

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
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Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania Institute for Translational Medicine and Therapeutics
Additional Information:
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Responsible Party: Garret A. FitzGerald M.D Chair, Department of Pharmacology- Director, Institute for Translational Medicine and Therapeutics, University of Pennsylvania Identifier: NCT00954096    
Other Study ID Numbers: 707275
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action